2018 Common Rule (45 CFR 46)
On January 19, 2017, the U.S. Department of Health and Human Services (HHS) and fifteen other federal departments and agencies announced revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as the Common Rule in 1991.
The 2018 Common Rule Requirements became effective January 21, 2019, with the exception of cooperative research (single IRB review) which will not be effective until January 20, 2020.
|2018 Common Rule Changes|
|Revised Common Rule||January 21, 2019
|Single IRB of Record||January 25, 2018
See updated CPHS Policies and Procedures
Summary of Changes to the Common Rule
|Revised Regulation||Summary of Changes||Revised UCB Documents|
45 CFR 46.101
|46.101(f) - When applicable, American Indian and Alaska Native Tribal Laws will be applied.|
45 CFR 46.102
45 CFR 46.103
|The elimination of the requirement that institutional review boards review grant applications or other funding proposals related to the research.|| |
|Exempt Research |
45 CFR 46.104
|Exempt categories 1-2 and 5 are further defined, and 6
remains the same. |
1: Normal educational practices not likely to adversely impact students’ opportunity to learn.
2: Criteria iii specifies that an IRB can conduct a limited review for studies in which identifiable information is obtained/recorded.
5: New section for research conducted by Federal employees.
New categories are 3-4, and 7-8 (not used at UCB):
3: Research involving benign behavioral interventions with adult subjects, in conjunction with the collection (verbal, written, data entry, audio/visual recording) of information is permitted with prospective consent and at least one of three additional criteria are met.
4: Secondary research for which consent is not required is permitted if at least one of three additional criteria are met.
UCB-specific category, #7, is changed to #70.
|IRB Review of Research |
45 CFR 46.109
|46.109(a) - Exempt Research that requires limited IRB
review as a condition of exemption. Limited IRB Review
is performed at an IRB Expedited Subcommittee meeting by
an IRB Chair or an IRB Chair-designee. |
46.109(f) - Continuing review is not required when:*
*Not applicable to FDA-regulated research, or industry-sponsored research.
|Criteria for IRB Approval |
45 CFR 46.111
|46.111(a)(3) & 46.111(b) - Vulnerable populations:
46.11(a)(8) Approval criteria for a limited IRB review (see above).
|Cooperative Research (sIRB) |
45 CFR 46.114
|The final rule mandates the use of a single IRB for multisite studies. Federal departments or agencies supporting or conducting the research can determine that the use of a single IRB is not appropriate for particular types of studies.||Required for NIH funded/supported research |
2020 Implementation for other Federal departments or agencies
|Informed Consent |
45 CFR 46.116
| || |
|Documentation of Informed Consent |
45 CFR 46.117
UC Berkeley Transition Plan
|Review Type||When was Initial IRB Approval Issued for the Research?||Is Transition to 2018 Common Rule Required?|
|Exempt||Prior to January 21, 2019||Researchers do not need to take any action. At time of the protocol’s next amendment, the exempt form will automatically update to the new regulations.|
|Exempt||On or after January 21, 2019||All new exempt protocols will adhere to the 2018 requirements, regardless of funding.|
|Non-Exempt||Prior to January 21, 2019||Federally funded research will need to transition to the 2018 requirements at time of next renewal. Non-federally funded research will not be required to transition.|
|Non-Exempt||On or after January 21, 2019||Federally funded research must follow the 2018 requirements. Non-federally funded research is encouraged to follow the 2018 requirements.|